lixisenatide
Trade name: adlyxin
Peptideapproved
Approved
Jul 27, 2016
Lixisenatide (trade name Adlyxin) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. — NCATS
Clinical trial activity
59 trials · 21 clinical orgs · 2 marketing orgs
Phase 1
7
Phase 2
41
Phase 3
33
Phase 4
10
Earliest trial started Feb 1, 2006 (NCT00299871)
Timeline
2000s
- Jun 8, 2001
Zealand Pharma — IND Organization
- Jun 8, 2001
Zealand Pharma — IND Organization
- Jan 1, 2006
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2008
Earliest Phase 3 Sponsor(trial)
- Jan 1, 2009
Earliest Phase 1 Sponsor(trial)
2010s
- Jul 27, 2016
Sanofi-Aventis — Earliest FDA Approval
- Jul 27, 2016
Sanofi-Aventis — NDA Secondary Org
- Jul 27, 2016
Sanofi-Aventis — NDA Organization
Indications
Approved for
Mechanism of action
GLP1R agonist
Combination products
soliqua
with insulin glargine
Also known as insulin glargine and lixisenatide
Approval history
- approvedJul 27, 2016
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaLixisenatide ↗
- NCATS74O62BB01U ↗
- ChEMBLCHEMBL2108336 ↗
Also known as
- adlyxin
- adlyxin
- adlyxin
- adlyxin
- adlyxin
- adlyxin
- adlyxin
- aqve-10010
- ave0010
- ave0010
- ave 0010
- ave-0010
- ave-0010
- ave-0010
- ave-0010
- ave 010
- ave-010
- des-38-proline-exendine-4 (heloderma suspectum)-(1-39)-peptidylpenta-l-lysyl-l-lysinamide
- des-38-proline-exendine-4 (heloderma suspectum)-(1-39)-peptidylpenta-l-lysyl-l-lysinamide
- des-38-proline-exendine-4 (heloderma suspectum)-(1-39)-peptidylpenta-l-lysyl-l-lysinamide
- despro38exendin-4(1-39)-lys6-nh2
- despro38exendin-4(1-39)-lys6-nh2
- iglarlixi
- insulin glargine / lixisenatide
- l-histidylglycyl-l-α-glutamylglycyl-l-threonyl-l-phenylalanyl-l-threonyl-l-seryl-l-α-aspartyl-l-leucyl-l-seryl-l-lysyl-l-glutaminyl-l-methionyl-l-α-glutamyl-l-α-glutamyl-l-α-glutamyl-l-alanyl-l-valyl-l-arginyl-l-leucyl-l-phenylalanyl-l-isoleucyl-l-α-glutamyl-l-tryptophyl-l-leucyl-l-lysyl-l-asparaginylglycylglycyl-l-prolyl-l-seryl-l-serylglycyl-l-alanyl-l-prolyl-l-prolyl-l-seryl-l-lysyl-l-lysyl-l-lysyl-l-lysyl-l-lysyl-l-lysinamide
- lixisenatida
- lixisenatida
- lixisenatide
- lixisenatide
- lixisenatide
- lixisenatide
- lixisenatide
- lixisenatide
- lixisenatide
- lixisenatide
- lixisenatide
- lixisenatide
- lixisenatide
- lixisénatide
- lixisénatide
- lyxumia
- lyxumia
- lyxumia
- lyxumia
- zp 10
- zp-10
- zp10a peptide
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05804513 | Phase 4 | Apr 17, 2023 | University of Tartu |
| NCT05413369 | Phase 3 | Jul 7, 2022 | Sanofi |
| NCT05114590 | Phase 4 | Dec 1, 2021 | Sanofi |
| NCT04196231 | Phase 4 | Jan 1, 2020 | University of Campania Luigi Vanvitelli |
| NCT03767543 | Phase 3 | Mar 4, 2019 | Sanofi |
| NCT03798080 | Phase 3 | Feb 19, 2019 | Sanofi |
| NCT03798054 | Phase 3 | Feb 15, 2019 | Sanofi |
| NCT03819790 | Phase 4 | Oct 2, 2018 | LMC Diabetes & Endocrinology Ltd. |
| NCT03529123 | Phase 3 | Jun 19, 2018 | Sanofi |
| NCT03439943 | Phase 2 | Jun 13, 2018 | Cure Parkinson's Trust, EUCLID, Réseau NS-Park, Sanofi, University of Toulouse |
| NCT03434119 | Phase 3 | Feb 20, 2018 | Sanofi |
| NCT02803918 | Phase 1 | May 17, 2017 | Sanofi |
| NCT03130426 | Phase 3 | May 1, 2017 | McMaster University, Sanofi |
| NCT02941367 | Phase 4 | Feb 23, 2017 | Sanofi |
| NCT02767596 | Phase 4 | Jul 12, 2016 | Laniado Medical Center |
| NCT02787551 | Phase 3 | Jul 6, 2016 | Sanofi |
| NCT02752412 | Phase 3 | May 1, 2016 | Sanofi |
| NCT02749890 | Phase 3 | May 1, 2016 | Sanofi |
| NCT02752828 | Phase 3 | May 1, 2016 | Sanofi |
| NCT02713477 | Phase 1 | Apr 1, 2016 | Sanofi |
Showing 20 of 59 trials
Page 1 / 3
Organizations
Research & Development (21)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sanofi | For profit | 48 | 44 | 4 | 2006 |
| Profil GmbH | For profit | 3 | 2 | 2 | 2009 |
| Cure Parkinson's Trust | Academic/Hospital | 1 | 0 | 1 | 2018 |
| EUCLID | For profit | 1 | 0 | 1 | 2018 |
| Free University of Amsterdam | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Laniado Medical Center | Academic/Hospital | 1 | 1 | 1 | 2016 |
| LMC Diabetes & Endocrinology Ltd. | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Lund University | Academic/Hospital | 1 | 1 | 1 | 2013 |
| McMaster University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| National Health and Medical Research Council, Australia | Government | 1 | 0 | 1 | 2013 |
| Novo Nordisk | For profit | 1 | 1 | 1 | 2013 |
| Réseau NS-Park | Academic/Hospital | 1 | 0 | 1 | 2018 |
| Sanofi-Aventis | For profit | 1 | 0 | 1 | 2015 |
| Seoul National University | Academic/Hospital | 1 | 1 | 1 | 2016 |
| University of Adelaide | Academic/Hospital | 1 | 1 | 1 | 2013 |
| University of Amsterdam | Academic/Hospital | 1 | 1 | 1 | 2014 |
| University of Campania Luigi Vanvitelli | Academic/Hospital | 1 | 1 | 1 | 2020 |
| University of Copenhagen | Academic/Hospital | 1 | 1 | 1 | 2015 |
| University of Tartu | Academic/Hospital | 1 | 1 | 1 | 2023 |
| University of Toulouse | Academic/Hospital | 1 | 1 | 1 | 2018 |
21 organizations
Page 1 / 2
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Sanofi-Aventis | For profit | NDA2 | Jul 27, 2016 |
| Sanofi-Aventis | For profit | NDA | Jul 27, 2016 |
| Zealand Pharma | For profit | IND | Jun 8, 2001 |